211. Do clinically equivalent dosing ratios exist between different formulations of botulinum neurotoxin A in the treatment of adult spasticity, dystonia, blepharospasm, and hemifacial spasm: A systematic review

Zhang, Younan; Coulton, Karen; Rosales, Raymond L.; Moore, Austen P; Plested, Melanie

doi:10.1016/j.toxicon.2014.11.214

Cited by 3 publications

(4 citation statements)

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“…Unlike that study, however, we did not use a fixed conversion ratio of OnaBoNT-A to AboBoNT-A, instead preferring to base our dosing decisions on the child's individual presentation at that time. In recent years, there has been considerable disagreement between the various studies conducted on this issue and many authors have concluded that there can be no fixed dose ratio between the products (13,14). To date, most published studies have focused on the gastrocnemiussoleus complex and/or hamstrings (1,7), and our data provide a useful insight into practical dosing for other proximal muscles of the lower limb.…”

Section: Table III Adverse Events In Onabotulinumtoxin-a (Onabont-a)mentioning

confidence: 80%

Switching from onabotulinumtoxin-A to abobotulinumtoxin-A in children with cerebral palsy treated for spasticity: A retrospective safety and efficacy evaluation

Dursun¹,

Akarsu²,

Gokbel³

et al. 2019

J Rehabil Med

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In the absence of head-to-head clinical trials, a retrospective observational study of 118 children with cerebral palsy who had switched botulinum toxin formulation (from onabotulinumtoxin-A to abobotulinumtoxin-A) due to a change in hospital policy was performed. The safety and tolerability profile of both formulations were similar. Likewise, the efficacy of treatment (measured 4-6 weeks post-injection) was found to be similar for all clinical measures assessed. This study indicates that switching from onabotulinumtoxin-A to abobotulinumtoxin-A is generally well-tolerated and therapeutic efficacy is maintained. Objectives: To determine whether switching from onabotulinumtoxin-A to abobotulinumtoxin-A in children with cerebral palsy is safe and whether therapeutic efficacy is maintained. Methods: This retrospective observational study of routine care included 118 children with cerebral palsy (mean age 81.4 months (standard deviation 38.9)) who had switched from onabotulinumtoxin-A to abobotulinumtoxin-A injections into their lower extremities due to a change in hospital policy. Analysis was limited to the final onabotulinumtoxin-A treatment-cycle prior to switch, and the first abobotulinumtoxin-A treatment-cycle following switch. The primary objective was to document the safety and tolerability of switching products. Efficacy endpoints included muscle tone, spasticity, and gait function based on Modified Ashworth Scale (MAS), Tardieu Scale (TS) and Observational Gait Scale (OGS) scores. Results: Treatment-emergent adverse events were recorded in 41 (34.7%) and 31 (26.3%) patients during the onabotulinumtoxin-A and abobotulinumtoxin-A treatment cycles, respectively. Treatment-related adverse events were reported in 5 patients in the onabotulinumtoxin-A treatment-cycle vs 7 in the abobotulinumtoxin-A treatment-cycle (p = 0.774). Treatment efficacy (4-6 weeks post-treatment) was similar in the onabotulinumtoxin-A and abobotulinumtoxin-A treatment-cycles for all variables (MAS, TS, OGS). Conclusion: In children with cerebral palsy, switching from onabotulinumtoxin-A to abobotulinumtoxin-A is safe and generally well-tolerated and therapeutic efficacy is maintained.

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Section: Table III Adverse Events In Onabotulinumtoxin-a (Onabont-a)mentioning

confidence: 80%

Switching from onabotulinumtoxin-A to abobotulinumtoxin-A in children with cerebral palsy treated for spasticity: A retrospective safety and efficacy evaluation

Dursun¹,

Akarsu²,

Gokbel³

et al. 2019

J Rehabil Med

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“…While the fixed dosing of both products does not allow for tailored dosing to the individual patient, it was chosen to ensure fair comparability between the two products and is reflective of routine clinical practice because the doses are in full alignment with the prescribing information for both products in the countries where the study is performed. Whereas other studies have imposed presumed conversion ratios between dosing [ 19 , 20 ], our dosing is entirely based on the approved prescribing information for both products, with the assumption that approval is based on optimal dosing. This may be especially important as surveys suggest that both onaBoNT-A and aboBoNT-A are often underdosed in real-world clinical practice [ 28 ].…”

Section: Strengths and Limitationsmentioning

confidence: 99%

“…Uncertainty regarding dose conversion ratios arises from inconsistent literature which includes wide variation in the patient populations, clinical settings, study designs, outcomes assessed, and injection techniques studied. This variability has resulted in a wide range of dosing ratios between BoNT-A products, with conversion factors ranging from 1:1.67 to 1:11 for onaBoNT-A: aboBoNT-A [ 19 , 20 ]. More recently, several authors have concluded that a single fixed ratio cannot be applied to all individuals [ 19 , 21 , 22 ].…”

Section: Introductionmentioning

confidence: 99%

“…This variability has resulted in a wide range of dosing ratios between BoNT-A products, with conversion factors ranging from 1:1.67 to 1:11 for onaBoNT-A: aboBoNT-A [ 19 , 20 ]. More recently, several authors have concluded that a single fixed ratio cannot be applied to all individuals [ 19 , 21 , 22 ]. Indeed, studies using a predefined dose ratio may be particularly misleading because they rely on the hypothesis that the defined doses of the different formulations are equivalent (and frequently fail to prove this hypothesis).…”

Section: Introductionmentioning

confidence: 99%

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AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol

et al. 2021

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Introduction The safety and efficacy of both abobotulinumtoxinA and onabotulinumtoxinA for upper limb spasticity are well established, but head-to-head comparisons are lacking. Methods DIRECTION is an international, randomized, double-blind, crossover study comparing the safety and efficacy of abobotulinumtoxinA with onabotulinumtoxinA in the management of upper limb spasticity at doses at or near maximum recommended in product labelling. Participants (18–75 years) will be randomized (1:1) to either one cycle of abobotulinumtoxinA (900U) followed by onabotulinumtoxinA (360U) or vice versa. To maintain blinding, a fixed volume (3.6 ml) will be injected into the target upper limb muscles (four wrist and finger flexors and biceps brachii). The second treatment cycle will begin at Week 12 if retreatment criteria are fulfilled, and if not, they will be reassessed every 4 weeks until they meet retreatment parameters. Planned Outcomes The primary hypothesis is that there is comparable safety between products; non-inferiority will be tested based on treatment-emergent adverse event (TEAE) rates from injection to Week 12. A secondary hypothesis is that abobotulinumtoxinA has longer duration of effect than onabotulinumtoxinA. This hypothesis will be tested with secondary efficacy endpoints, including injection cycle duration, Modified Ashworth Scale, Disability Assessment Scale and Physician Global Assessment. Trial Registration EudraCT ( http://eudract.ema.europa.eu ): 2021-000161-32 and Clinicaltrials.gov ( http://clinicaltrials.gov ): NCT04936542. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01896-3.

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AbobotulinumtoxinA Efficacy and Safety in Children With Equinus Foot Previously Treated With Botulinum Toxin

Dabrowski

Bonikowski²,

Gormley

et al. 2018

Pediatric Neurology

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211. Do clinically equivalent dosing ratios exist between different formulations of botulinum neurotoxin A in the treatment of adult spasticity, dystonia, blepharospasm, and hemifacial spasm: A systematic review

Cited by 3 publications

References 0 publications

Switching from onabotulinumtoxin-A to abobotulinumtoxin-A in children with cerebral palsy treated for spasticity: A retrospective safety and efficacy evaluation

Switching from onabotulinumtoxin-A to abobotulinumtoxin-A in children with cerebral palsy treated for spasticity: A retrospective safety and efficacy evaluation

AbobotulinumtoxinA Versus OnabotulinumtoxinA in Adults with Upper Limb Spasticity: A Randomized, Double-Blind, Crossover Study Protocol

AbobotulinumtoxinA Efficacy and Safety in Children With Equinus Foot Previously Treated With Botulinum Toxin

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